Britt Jones, Senior Manager, Chemistry and Package Testing Services, WuXi AppTec06.04.24
In medical device manufacturing, package integrity is critical to ensure products reach patients in pristine, sterile condition. Today, the ASTM F1980-21 standard is the cornerstone of this assurance. The methodologies outlined in this standard guide manufacturers in simulating the aging process under controlled conditions. These efforts help predict the lifespan of packaging and ensure the packaging maintains its protective qualities throughout the product’s shelf life.
Just as ASTM F1980-21 focuses on packaging and medical device longevity, its sister standard, ASTM D4169-23—revised in 2023—plays the same role for shipping containers, ensuring they withstand the rigors of transportation. Together, these standards form a dynamic framework that supports the medical device industry’s dual imperatives of rapid innovation and uncompromising safety.
Here, we delve into the importance of understanding and implementing these standards. We explore how accelerated and real-time aging studies under ASTM F1980-21 complement the physical stress tests of ASTM D4169-23, creating comprehensive safeguards for medical devices from production to patient.
These studies mimic the effects of natural aging within a shorter period by exposing packaging materials to elevated temperatures and increased humidity levels. The controlled stress conditions outlined in ASTM F1980-21 provide a faster route to estimate how well a product will hold up over time. The specific humidity and temperature conditions for these tests are chosen based on the materials’ known stability characteristics and the environmental conditions they are expected to encounter during shipping and storage.
For instance, a typical accelerated aging study might involve exposing medical devices and packaging systems to temperatures between 50°C and 60°C with varying humidity levels, depending on the material’s susceptibility to moisture. These conditions are designed to accelerate the rate of the materials’ chemical reactions, providing a snapshot of how a product might age over weeks, months, or years. This process helps manufacturers preemptively identify potential material degradations or failures, allowing adjustments before products are distributed.
Accelerated aging tests have strategic importance, too. They provide empirical data manufacturers can use to develop product claims, including labeling and expiration dates. This data is essential to achieving regulatory approval, maintaining consumer trust, and safeguarding public health.
While accelerated aging tests provide a relatively quick analysis of material behavior under stress, they cannot entirely replicate real-time aging nuances. Thus, it is crucial to conduct continuous real-time aging studies in parallel to validate long-term package integrity. Real-time aging studies involve storing the packaging under normal conditions for the same duration the product is expected to remain on the shelf. This data should complement accelerated aging tests, offering a comprehensive assessment of how materials perform under variable conditions.
This dual approach ensures the packaging maintains its integrity, protecting the medical device from contamination or damage throughout its intended shelf life. Device manufacturers must integrate both types of data into their package validation to meet regulatory requirements and ensure their products can withstand unforeseen challenges.
In an industry where rapid innovation and stringent safety standards are priorities, potential changes to the standard governing those processes should be heeded. Being proactive about potentially shifting expectations regarding ASTM F1980-21 will help maintain manufacturers’ standards of quality and reliability and keep development timelines intact.
For example, polyamides (nylons) are particularly sensitive to moisture, which can act as a plasticizer, reducing the glass transition temperature and leading to increased flexibility and decreased stability and strength. On the other hand, materials like polyolefins are less affected by humidity but may still experience some degree of physical change.
Understanding these material-specific reactions to humidity is crucial because it helps set appropriate accelerated aging conditions that mimic the actual challenges products will face during their market life. By incorporating precise humidity controls in accelerated aging protocols, manufacturers can more accurately predict the real-world performance of their products’ packaging, leading to safer and more reliable medical devices—ultimately contributing to better patient outcomes.
Shipping containers and systems are vital in protecting products during transportation, making ASTM D4169-23 essential for manufacturers globally. Like ASTM F1980-21, which focuses on the accelerated aging of sterile barrier systems and medical devices, ASTM D4169-23 aims to guarantee the shipping containers maintain their integrity and protective capabilities throughout the distribution process. Both standards are crucial to ensure that packaging can withstand specific stress factors—ASTM F1980-21 deals with time-related degradation under controlled conditions; ASTM D4169-23 addresses the physical rigors of the shipping environment.
For medical device manufacturers producing and distributing sensitive and valuable products, staying updated with these standards is even more crucial. Keeping up to date with ASTM D4169-23 and ASTM F1980-21 will help mitigate risks associated with product distribution and storage, ensuring products maintain efficacy and reach consumers in optimal condition.
A proactive approach might also involve participating in standards development or conducting internal studies to anticipate future regulatory changes. Staying ahead of these changes can help manufacturers ensure compliance and minimize disruptions.
The latest revision to ASTM F1980-21 recommends introducing relative humidity to accelerated aging protocols to mimic the passage of time that medical devices and their packaging systems will experience during their lifetimes. To ensure a successful package validation, medical device manufacturers must have in-depth knowledge of the materials used in their devices and packaging materials so they can avoid hydrolytic degradation of their package systems and devices during accelerated aging.
Navigating market changes can be complex, particularly for manufacturers without extensive testing facilities or expertise in regulatory compliance. Trusted lab partners play a critical role by offering specialized testing services and help with interpreting and implementing updated standards and evolving regulatory expectations. This ensures that medical devices remain compliant and competitive in the market. Such partnerships are invaluable for manufacturers aiming to succeed in a dynamic market where safety, durability, and compliance are paramount.
Britt Jones is a senior manager of Chemistry and Package Testing services for medical devices, biologics, and combination products at WuXi AppTec, a global company with operations across Asia, Europe, and North America. Wuxi AppTec provides a broad portfolio of R&D and manufacturing services that enable the pharmaceutical and life sciences industries to advance discoveries and deliver groundbreaking treatments to patients. Jones serves on the ASTM Committee on Packaging (ASTM D-10) and is a member of and certified by the International Safe Transit Association (ISTA) and the Institute of Packaging Professionals (IoPP). With more than 20 years of operations and project management experience at WuXi AppTec, Jones’s broad knowledge in microbiology, chemistry, sterility, bioburden, microbial ID, and packaging enables him to provide the scientific and regulatory advice that medical device development needs to avoid pitfalls and failure points. As an industry expert, Jones excels in packaging validation and cold chain transportation studies.
Just as ASTM F1980-21 focuses on packaging and medical device longevity, its sister standard, ASTM D4169-23—revised in 2023—plays the same role for shipping containers, ensuring they withstand the rigors of transportation. Together, these standards form a dynamic framework that supports the medical device industry’s dual imperatives of rapid innovation and uncompromising safety.
Here, we delve into the importance of understanding and implementing these standards. We explore how accelerated and real-time aging studies under ASTM F1980-21 complement the physical stress tests of ASTM D4169-23, creating comprehensive safeguards for medical devices from production to patient.
Accelerated and Real-Time Aging Studies
Accelerated aging studies validate the longevity and effectiveness of medical device packaging while real time data is being generated. What makes these studies so valuable is that they allow manufacturers to quickly evaluate the impact of time on the integrity of packaging materials and their ability to maintain a sterile barrier, as well as medical device integrity.These studies mimic the effects of natural aging within a shorter period by exposing packaging materials to elevated temperatures and increased humidity levels. The controlled stress conditions outlined in ASTM F1980-21 provide a faster route to estimate how well a product will hold up over time. The specific humidity and temperature conditions for these tests are chosen based on the materials’ known stability characteristics and the environmental conditions they are expected to encounter during shipping and storage.
For instance, a typical accelerated aging study might involve exposing medical devices and packaging systems to temperatures between 50°C and 60°C with varying humidity levels, depending on the material’s susceptibility to moisture. These conditions are designed to accelerate the rate of the materials’ chemical reactions, providing a snapshot of how a product might age over weeks, months, or years. This process helps manufacturers preemptively identify potential material degradations or failures, allowing adjustments before products are distributed.
Accelerated aging tests have strategic importance, too. They provide empirical data manufacturers can use to develop product claims, including labeling and expiration dates. This data is essential to achieving regulatory approval, maintaining consumer trust, and safeguarding public health.
While accelerated aging tests provide a relatively quick analysis of material behavior under stress, they cannot entirely replicate real-time aging nuances. Thus, it is crucial to conduct continuous real-time aging studies in parallel to validate long-term package integrity. Real-time aging studies involve storing the packaging under normal conditions for the same duration the product is expected to remain on the shelf. This data should complement accelerated aging tests, offering a comprehensive assessment of how materials perform under variable conditions.
This dual approach ensures the packaging maintains its integrity, protecting the medical device from contamination or damage throughout its intended shelf life. Device manufacturers must integrate both types of data into their package validation to meet regulatory requirements and ensure their products can withstand unforeseen challenges.
In an industry where rapid innovation and stringent safety standards are priorities, potential changes to the standard governing those processes should be heeded. Being proactive about potentially shifting expectations regarding ASTM F1980-21 will help maintain manufacturers’ standards of quality and reliability and keep development timelines intact.
Humidity’s Impacts on Accelerated Aging Studies
Humidity is critical in accelerated aging studies because it impacts various packaging materials and medical devices, especially polymers. Polymers are widely used in medical devices and their packaging because of their versatility and durability, but they exhibit different behaviors under varying humidity conditions. High humidity levels can lead to hydrolysis, a chemical breakdown process where water molecules interact with polymer chains, potentially leading to a loss of mechanical strength, changes in color, and other physical alterations that may compromise the integrity of the devices and packaging systems.For example, polyamides (nylons) are particularly sensitive to moisture, which can act as a plasticizer, reducing the glass transition temperature and leading to increased flexibility and decreased stability and strength. On the other hand, materials like polyolefins are less affected by humidity but may still experience some degree of physical change.
Understanding these material-specific reactions to humidity is crucial because it helps set appropriate accelerated aging conditions that mimic the actual challenges products will face during their market life. By incorporating precise humidity controls in accelerated aging protocols, manufacturers can more accurately predict the real-world performance of their products’ packaging, leading to safer and more reliable medical devices—ultimately contributing to better patient outcomes.
The Role of ASTM D4169-23
ASTM D4169-23 regulates how shipping containers and their systems perform, providing a rigorous protocol for assessing the durability of packaging in the distribution environment. This standard includes tests that simulate a variety of physical and environmental stressors such as compression, vibration, impact, and exposure to different climatic conditions, reflecting the real-world challenges products may face during transportation.Shipping containers and systems are vital in protecting products during transportation, making ASTM D4169-23 essential for manufacturers globally. Like ASTM F1980-21, which focuses on the accelerated aging of sterile barrier systems and medical devices, ASTM D4169-23 aims to guarantee the shipping containers maintain their integrity and protective capabilities throughout the distribution process. Both standards are crucial to ensure that packaging can withstand specific stress factors—ASTM F1980-21 deals with time-related degradation under controlled conditions; ASTM D4169-23 addresses the physical rigors of the shipping environment.
For medical device manufacturers producing and distributing sensitive and valuable products, staying updated with these standards is even more crucial. Keeping up to date with ASTM D4169-23 and ASTM F1980-21 will help mitigate risks associated with product distribution and storage, ensuring products maintain efficacy and reach consumers in optimal condition.
The Need for a Proactive Approach
Regulatory standards for medical devices and their packaging continually evolve to keep pace with new scientific discoveries and technological advancements. Changes in regulatory standards often focus on enhancing patient safety and product reliability, which may require manufacturers to adopt new testing protocols or revise existing ones. Manufacturers must remain vigilant and proactive by engaging with regulatory bodies, participating in industry workshops, and staying updated through continuous professional development and consultation.A proactive approach might also involve participating in standards development or conducting internal studies to anticipate future regulatory changes. Staying ahead of these changes can help manufacturers ensure compliance and minimize disruptions.
The Bottom Line
Last year’s revision of ASTM D4169 included increasing the default shipping density factor to 12 lbs./ft3 from 10 lbs./ft3, which will increase the vehicle stacking top load required for a specific shipper configuration, thus ensuring durability in the distribution environment. Routine revisions clearly demonstrate how standards can evolve to meet the distribution and shipping industry’s changing needs. Staying up to date with these changes is vital for manufacturers to ensure compliance, optimize packaging performance, and maintain product integrity.The latest revision to ASTM F1980-21 recommends introducing relative humidity to accelerated aging protocols to mimic the passage of time that medical devices and their packaging systems will experience during their lifetimes. To ensure a successful package validation, medical device manufacturers must have in-depth knowledge of the materials used in their devices and packaging materials so they can avoid hydrolytic degradation of their package systems and devices during accelerated aging.
Navigating market changes can be complex, particularly for manufacturers without extensive testing facilities or expertise in regulatory compliance. Trusted lab partners play a critical role by offering specialized testing services and help with interpreting and implementing updated standards and evolving regulatory expectations. This ensures that medical devices remain compliant and competitive in the market. Such partnerships are invaluable for manufacturers aiming to succeed in a dynamic market where safety, durability, and compliance are paramount.
Britt Jones is a senior manager of Chemistry and Package Testing services for medical devices, biologics, and combination products at WuXi AppTec, a global company with operations across Asia, Europe, and North America. Wuxi AppTec provides a broad portfolio of R&D and manufacturing services that enable the pharmaceutical and life sciences industries to advance discoveries and deliver groundbreaking treatments to patients. Jones serves on the ASTM Committee on Packaging (ASTM D-10) and is a member of and certified by the International Safe Transit Association (ISTA) and the Institute of Packaging Professionals (IoPP). With more than 20 years of operations and project management experience at WuXi AppTec, Jones’s broad knowledge in microbiology, chemistry, sterility, bioburden, microbial ID, and packaging enables him to provide the scientific and regulatory advice that medical device development needs to avoid pitfalls and failure points. As an industry expert, Jones excels in packaging validation and cold chain transportation studies.